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23andMe Stops Offering Genetic Tests Related To Health

23andMe, the genetic testing startup backed by Google Ventures and Facebook billionaire Yuri Milner, will stop offering test results related to customer’s health in order to comply with a warning letter sent by the Food and Drug Administration on November 22. The company will continue to sell its kits to people who want to use genetics to learn about their ancestry, and to allow customers who bought kits before the warning letter was set to see their existing test results. Customers will still be able to download their own raw data, and 23andMe will continue to use the data it collects for its own research.

The decision seems to indicate that 23andMe’s conflict with the FDA wasn’t a planned move to try and change policy or set off a legal maneuver, as some fans and defenders of the company hoped, but simply a mis-step. The FDA said in its warning letter that 23andMe had gone quiet for six months, at the same time making more health-related claims for its test, including a video on its Web site in which a patient and her doctor testified that the 23andMe kit helped her learn she had celiac disease, a digestive disorder.

For years the FDA and 23andMe had been in a kind of detente in which the agency allowed the kits to be sold, 23andMe tried to walk a fine line between providing scientific information and being a medical test, and both sides tried to figure out how the company had been regulated. The bolder claims apparently pushed the agency to move. 23andMe had been saying it hoped to sell a million kits by the end of the year. That goal is now in doubt.

“We remain firmly committed to fulfilling our long-term mission to help people everywhere have access to their own genetic data and have the ability to use that information to improve their lives,” said Anne Wojcicki, co-founder and CEO of 23andMe in a prepared statement. “Our goal is to work cooperatively with the FDA to provide that opportunity in a way that clearly demonstrates the benefit to people and the validity of the science that underlies the test.”

In a letter published Tuesday in the Wall Street Journal, FDA Commissioner Margaret Hamburg insisted that regulatory review is necessary. She pointed to the agency’s willingness to approved DNA sequencers made by Illumina, and argued that the agency saw value in 23andMe’s approach. “We agree that access to tests through a direct-to-consumer model will allow consumers to take a more active role in certain aspects of their health,” she wrote. “The agency’s desire to review these particular tests is solely to ensure that they are safe, do what they claim to do and that the results are communicated in a way that a consumer can understand.”

But she also wrote that the FDA is “continuing our ongoing dialogue with the company in order to bring a safe, effective and trusted product to the market.” The clear implication: despite having sold hundreds of thousands of its kits, in the FDA’s view 23andMe is not on the market yet.

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